Identity
- Trade Name
- Irrisept FDA UDI
- Generic Name
- Pressure-regulated wound irrigation solution applicator, manual FDA UDI
- Device Name
- Irrisept Wound Debridment and Cleansing System FDA UDI
- Model / Reference
- ISEPT-450-STU FDA UDI
- Description
- Irrisept Wound Debridment and Cleansing System FDA UDI
Identifiers
- Catalog Number
- 9001 FDA UDI
- Primary DI / UDI-DI
- 10842351190019 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 450 Milliliter FDA UDI
Irrisept by Irrimax Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Irrimax Corporation
Sources (1)
- FDA UDI 134e062c-25ab-4747-9ef8-c90faab1adae 38 fields · synced Jun 8, 2026